ABSTRACT
INTRODUCTION Specifications and stability of parenteral products are set in the broader context of drug product development of small molecules, biologics, and devices. The specifications for a finished pharmaceutical product are an accepted list of requirements that a product must meet before it is released into distribution. Typically, these requirements are laboratory tests and associated acceptance criteria. International Conference on Harmonisation (ICH) Q6A (1) provides a suitable working definition of specifications. For purposes of this chapter, the definition should be broadened to extend beyond “new” drug substances and products.
